High Frequency Oscillation in Pediatric Epilepsy Surgery

Not Applicable

Completed

• Conditions: Pediatric Epilepsy; High Frequency Oscillation; Epilepsy Surgery

• Registration Number: NCT03790280
• Lead Sponsor: University of California, Los Angeles

Brief Summary

High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery guided by the combination of HFO on ECoG and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.

Detailed Description

Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the gold standard.

High frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine if HFO- tailored surgery combining HFOs and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Study Timeline

• Study Start: 2018-11-29
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-31
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Results First Submitted: 2022-03-22
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Results First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age 0-21 years
• Refractory focal epilepsy
• Planned resective epilepsy neurosurgery
• Includes intraoperative or extraoperative electrocorticography with grids
• Planned resective epilepsy surgery approved by institutional surgery board

Exclusion Criteria

• Subjects undergoing non-resective neurosurgery
• Does not include intraoperative or extraoperative electrocorticography with grids
• Planned resective surgery is a hemispherectomy/hemispherotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative Seizure-free Rate	1 year after surgery	The primary outcome measure is the number of patients seizure-free after surgery in the treatment arm of combined HFO and standard of care, compared to the number of patients seizure-free in the control arm of standard of care alone, at 1 year after surgery.

Secondary Outcome Measures

Name	Time	Method
Post-operative Complication	1 year after surgery	Number of participants experiencing surgical complications

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States